Friday, January 25, 2013

Bartlett – DOJ Says Remove-From-The-Market Claims Preempted

It’s written somewhat strangely – weak at the
beginning, strong at the end – but the Department of Justice’s amicus curiae brief , filed
yesterday in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S.
pending), eventually gets to the right place.That is, even the generally anti-preemption political leadership of this
FDA and DoJ took the only institutionally logical position that they could take
and told the Supreme Court that, yes, state tort claims asserting that an
FDA-approved product should have been removed from the market altogether were
impliedly preempted.

Because we like good news (and still can use some
after Stengel and Weeks), we flip right to the back of the DoJ’s Bartlett brief.The last substantive paragraph
states:

Federal law would preempt a pure defective-drug-design
claim that required a jury to second-guess FDA’s safety determination, without
any further need to find the existence of new and scientifically significant
evidence that rendered the product misbranded under federal law.

Let’s look at this.First of all, what’s this “pure” design defect business?As we said above, the DoJ brief starts out
weakly, trying to turn Bartlett into something it wasn’t in order to
avoid what it was.Instead of what
really went on at trial (the trial court allowing plaintiffs’ counsel to ask
the jury to flip a bird
at the FDA), the DoJ first portrayed the verdict as based primarily on an
“unreasonably dangerous even with warnings” theory under Restatement (Second)
of Torts §402A, comment k (1965).DoJ br. at 14-18.The primary purpose of that
argument was to reduce Bartlett to a “nothing to see here” misapplication
of Mensing.

But it wasn’t, and the Court wouldn’t have taken
such a case.Rather, the trial court
construed New Hampshire law as allowing a design defect claim based on pure
risk utility factors without any need for an alternative design, and the First Circuit
converted that theory on appeal to the “remove-from-the-market” claim that the
Supreme Court actually granted certiorari to
review.So eventually, DoJ had to come
to grips with what is actually at issue: that the trial court told the jury it
could − and plaintiff’s counsel told the jury it should − find that the FDA
should not have approved a drug that it did approve:

[The District Court] instructed the jury that it . . .
was free to give FDA’s approval “as much or as little weight as you think it
deserves. . . .”[Plaintiff’s counsel] “argued that sulindac was a “needless and useless
drug. . . .”Counsel
asserted that FDA merely “rubber stamped” the ANDA . . ., and that
“no evidence (showed) that FDA has ever done a focused analysis on (s)ulindac”
to justify its “be(ing) on the market.”FDA, counsel asserted, lacks “expertise in risk⁄benefit assessment” and
“impos(es) a significant risk to . . . the safety of the public”
because it is unable to perform its “mission to monitor drug safety for any
class of drugs.”

DoJ br. at 10-11 (quoting trial record).Given this view of the law and the evidence,
it’s hardly surprising that the Bartlett jury, applying only state law,
told the FDA to pound sand and decided that an FDA-approved drug simply
shouldn’t be sold at all.That’s the
“pure” theory that DoJ addresses in the most interesting part of its brief.

As the first block quote above indicates, the FDA supports
preemption – and does so without any use of “generic” as an adjective. That's important. The FDA states that remove-from-the-market
claims are preempted as to all drugs
(and presumably all other products it regulates):

Brand-name and generic drugs should be treated the same for purposes of
design-defect claims. . . .[T]he active ingredient in a generic drug must be the same as that in
the brand-name drug.The generic
manufacturer may not alter that ingredient without prior FDA approval.But the
same is true of the manufacturer of a brand-name drug. for both, any
change that created a new active ingredient would require prior FDA
approval. . . .[P]reemption in the generic-drug context, just as in the brand-name-drug context, should not be
defeated on the rationale that the manufacturer could always comply with state
law by declining to provide the very drug whose availability Congress sought to
provide.

DoJ br. at 30-31 (citations and footnote omitted)
(emphasis added).We’ve received the
same bone-headed response from an appellate court in a branded case, seeWimbush v. Wyeth, 619 F.3d 632, 645 (6th Cir. 2010) (our #1 worst caseof 2010), so we know that allowing state juries to order federally approved drugs off
the market is just as preemptive a conflict (and just as absurd a theory) in branded
as in generic cases.

We note that while the DoJ to some extent addresses
a straw man – the form of design defect described in Restatement (Third) of Torts,
Products Liability §6(c) (1998), which it concedes has not been accepted to “any
significant degree” (DoJ br. at 20) – this reasoning is also relevant to the
even more extreme so-called “categorical liability” design defect claims that the Third Statement
rejected, which are precisely what the plaintiff was permitted to pursue in Bartlett.Since none of these now mostly discredited
meat-axe design-related theories includes an caveat approaching the “new and
scientifically significant evidence that rendered the product misbranded under
federal law” qualifier added by DoJ, the government’s position is effectively
that all remove-from-the-market theories asserted in tort cases against
FDA-approved products are preempted.

That’s as it should be.

We particularly recommend DoJ’s discussion of why
failure to withdraw claims inherently conflict and interfere with the FDA’s
parallel post-marketing processes – because plaintiffs (including in Bartlett)
have made contrafactual statements about the FDA’s post-marketing authority,
leading some courts into error as to “pharmacovigilence”:

Congress has further charged FDA with monitoring post-marketing
drug safety.A manufacturer must
maintain extensive clinical records and make numerous reports to
FDA. . . .Those duties
apply to manufacturers of generic drugs as well as the brand-name
drug. . . .

The Act provides that FDA shall withdraw approval of a
drug if, inter alia, it finds that
the drug is not safe for the uses identified at the time of the drug’s approval
or is not effective as claimed for those uses.Approval may be withdrawn only following procedures that afford the manufacturer
due process and the opportunity for a hearing.Since 2007, FDA may also require (not merely request) labeling changes.

FDA’s ongoing risk-benefit analysis will sometimes take
into account the availability of more effective or less risky alternatives
. . . .FDA did not
request withdrawal of sulindac. . . .

In the face of this elaborate regulatory regime
instituted to safeguard the national market and protect consumers throughout
the United States, and the extensive commitment of public and private resources
to those ends, it would be inconsistent with the FDCA to conclude that a
manufacturer must abandon a market it has been approved by FDA to enter in
order to avoid violating a duty recognized by a jury under state tort law that deems
its product unsafe.

By requiring a jury independently to balance the health
risks and benefits of FDA-approved uses of a drug and to determine if the drug
is “unreasonably dangerous” for those uses, a state with a pure design-defect product-liability
law would force the jury to second-guess FDA’s safety determination, which
balances the drug’s therapeutic risks and benefits for its labeled uses.Such ad-hoc reconsiderations on a
state-by-state and lawsuit-by-lawsuit basis would undermine FDA’s drug-safety
determinations, which are made based on sound scientific judgments by an expert
federal agency with appropriate access to pertinent safety data, and the
assurance that FDA’s approval provides for all participants in the market.

DoJ br. at 26-28 (various stuff omitted).

DoJ also distinguished the heck out of Wyeth v.
Levine, 555 U.S. 555 (2009), which is probably the worst prescription drug
decision of all time (at least as to preemption):

Levine involved “newly acquired information undermining its drug’s safety” that the defendant had “failed to strengthen its labeling as specifically contemplated by FDA’s CBE regulation.Id.

Levine found no obstacle preemption in “FDA’s labeling approvals, and the mere possibility that FDA would disapprove a manufacturer’s subsequent enhanced warning.”Id. at 32.

Levine “does not categorically extend to all claims,” and in particular does not extend to design claims, because “because a manufacturer cannot unilaterally alter the design (unlike the labeling) of a drug.”Id.

Unlike the FDA’s position in Levine, FDA drug approval as a “an expert judgment that the drug’s therapeutic benefits outweigh its risks” is a “longstanding interpretation” of the FDCA.Id. at 32-33.

The claims at issue in Bartlett fit within Levine’s “recogni[tion] that some state-law claims might well frustrate the achievement of congressional objectives.”Id. (quoting Levine, 555 U.S. at 581).

So the good news is that, after some hemming and
hawing, the DOJ did the right thing in Bartlett.

The bad news is the hemming and hawing.Whether a state-law jury should be allowed to
say “no” to the marketing of a product after the FDA has said “yes” is hardly “difficult
and close.” DoJ br. at 12.This type of
absolute and utter conflict between state and federal law is a no-brainer,
since 1913, when the Court decided in McDermott v. Wisconsin, 228 U.S.
115 (1913), that a state couldn’t ban FDA-approved dairy products.

Moreover, it was egregious and unnecessary for DoJ
to advocate exceptions for Levine branded labeling claims or Riegel
parallel claims, br. at 23-24, since as the brief admits, “neither of the
foregoing theories is available here.”Id.
at 24.Even worse is DoJ’s backhanded
endorsement of a “state-law duty not to market the drug in the same
circumstances,” parallel to federal “misbranding” law as not preempted.Id.Not only was (1) no such claim raised in Bartlett, and (2)
“parallel” claims analysis isn’t an implied preemption concept, but generally
there is no state-law cause of action for failure to recall, as we discussed
here and here,
among other places.We hope the Supreme
Court won’t have time for such irrelevant nuances when it decides Bartlett,
but anything that gives comfort to bizarre new tort theories we can’t stomach.

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This blog contains the personal views of the Blogging Team identified below (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Please read the DISCLAIMER about the nature of this blog, and understand that you are accepting its terms, before reading any of the posts here.

Blogging Team

James M. Beck is Counsel resident in the Philadelphia office of Reed Smith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). he wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He can be reached at jmbeck@reedsmith.com.

Stephen McConnell has authored articles and chapters on product liability (though nothing as snappy or authoritative as Beck's book) and has tried drug and device cases that managed to evade the pretrial gauntlet. He is a partner in the Philadelphia office of Reed Smith and can be reached at smcconnell@reedsmith.com.

Michelle Hart Yeary is a seasoned products liability litigator who focuses on attempting to bring order to the chaos that is mass torts, concentrating on the practicalities and realities of defending coordinated and multidistrict litigation. She is counsel in the Princeton office of Dechert LLP and can be reached at michelle.yeary@dechert.com.

John J. Sullivan is a products liability and commercial litigator, having authored articles on mass torts and securities litigation and presented on trial advocacy. He is experienced in mass tort litigation, with a particular emphasis on scientific and regulatory issues, as well as having experience in complex commercial, securities class action and corporate governance litigation. He is a partner in the downtown Manhattan and New Jersey offices of Cozen O'Connor and can be reached at jsullivan@cozen.com.

Eric L. Alexander is a partner in Reed Smith’s Washington office. He has spent almost his entire career representing drug and device companies in product liability litigation from discovery through motions, trials, and appeals, usually on the right side of the v. He is particularly interested in medical and proximate cause and the intersection of actual regulatory requirements and the conduct that plaintiffs allege was bad, which covers quite a bit. He can be reached at ealexander@reedsmith.com.

Steven J. Boranian is a partner in Reed Smith’s San Francisco office, where he focuses his practice on representing drug and medical device companies in product liability and other kinds of litigation. He has handled drug and device matters from pre-litigation demands to appeals and all points in between, with particular interests in “mass” proceedings and class actions, to the extent the latter should ever be allowed in the drug and medical device context. He can be reached at sboranian@reedsmith.com.

Rachel B. Weil is counsel in Reed Smith’s Philadelphia office. Except for a brief, misguided trip to the “dark side,” Rachel has spent her whole career defending drug and device manufacturers in product liability litigation and in government actions arising from such litigation. While she laments the single-plaintiff drug cases of her youth, she loves nothing better than a good mass tort. She can be reached at rweil@reedsmith.com
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